Development & Deployment of a Risk Based Compliance Turnaround … · 2005-08-24 · The FDA...
Transcript of Development & Deployment of a Risk Based Compliance Turnaround … · 2005-08-24 · The FDA...
Development & Deployment of a Development & Deployment of a Risk Based Compliance Risk Based Compliance
Turnaround StrategyTurnaround Strategy
John R. Pinion IIJohn R. Pinion IIGenentech, Inc.Genentech, Inc.
The FDA Regulatory and Compliance The FDA Regulatory and Compliance SymposiumSymposium
August 24 August 24 –– 26, 200526, 2005
The FDA Regulatory & Compliance Symposium Page 2
Development & Deployment of a Risk Based Compliance Turnaround Strategy
AgendaAgenda1. Objectives2. Keys to Success3. Risk Triggers4. Getting Started / Expectations5. Business Assessment6. Risk Assessment7. Risk Control / Mitigation8. Communication and Timing9. Execution10. Measurement / Effectiveness Review11. Questions
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
ObjectivesObjectives• Reduce Overall Patient Risk• Reduce Compliance Risk• Improve Overall Business Performance• Focus Resources• Improve Customer Satisfaction• Improve Operating Mechanisms & Management
Visibility• Reset Performance Expectations
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Keys to SuccessKeys to Success1. Senior Management Recognition/Understanding of Issues2. Comprehensive Evaluation / Assessment of Business3. Effective Analysis of the Results of the Business Evaluation
(risk / gaps)4. Review of Organization and Talent5. Development of a Risk Analysis / Risk Management6. Creation of a Progress Measurement Approach7. Senior Management Acceptance of Approach8. Broad Communication of Need for Change and Action Plan9. Adequate Resources to Execute Strategy10. Implementation of Routine Senior Management Review Process11. Effectiveness Review of Mitigation Actions
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Risk TriggersRisk Triggers• Change in CEO & Other Senior Management
Changes• Restructuring / Mergers• Products
– New Area– New Molecular Entity
• RIF – Process Support Staff
• Regulatory Agency Quality Indicators– FCAs– Complaint Trends or Product Field Performance– Lack of Procedure Maintenance to Current cGMP's
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started / ExpectationsGetting Started / Expectations• Define
– Inputs to Be Included in the Business Assessment– Risk Analysis / Management Model (ISO 14971)– Cross Functional Risk Management Team– Outputs of Process
• Develop and Deploy Measurement System• Identify
– Risks– Mitigation Actions
• Verify Effectiveness of Mitigations• Establish / Initiate Communication with Appropriate
Agencies
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started / ExpectationsGetting Started / Expectations
• Product Performance– FCAs– CAPAs– Complaints– Process Performance
• Quality Systems– 8 Key Systems
• Business Processes• Facility Design / Performance• Infrastructure• Talent / Organization• Culture• Resources
– Personnel– Capital
• Product Performance– FCAs– CAPAs– Complaints– Process Performance
• Quality Systems– 8 Key Systems
• Business Processes• Facility Design / Performance• Infrastructure• Talent / Organization• Culture• Resources
– Personnel– Capital
• Product Decisions• Process Improvement Review• Quality System Performance• Business Process
Performance• Facility / Capital Decisions• Organization / Talent Review
Results / Decisions• Legacy Issue CA/PA• Operating Mechanism
Decisions• Progress (Score Card)
Measurement• Results of Effectiveness
Review
• Product Decisions• Process Improvement Review• Quality System Performance• Business Process
Performance• Facility / Capital Decisions• Organization / Talent Review
Results / Decisions• Legacy Issue CA/PA• Operating Mechanism
Decisions• Progress (Score Card)
Measurement• Results of Effectiveness
Review
InputsInputs OutputsOutputsInput Process Output Model (Example) Input Process Output Model (Example)
Risk Analysis Process
Risk Analysis Process
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Stop
Decision
No
Yes
ID of all known andforeseeable gaps
Estimate risk associatedwith each gap
Implement actions
Verify effectiveness ofactions
Re-assess risk
Determine if postmitigation risk is
acceptable
Verify documentation iscomplete
Yes
Yes
Determine if mitigationis necessary
Identify Products, Systems, Facilities etc. to be included in process
No
Prioritize mitigation actions
Determine ifmitigation is feasible
No
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started/ ExpectationsOverview –Risk ManagementProcess
Getting Started/ ExpectationsOverview –Risk ManagementProcess
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started / ExpectationsResource CommitmentGetting Started / ExpectationsResource Commitment
Time
Res
ourc
e C
omm
ittm
ent
Time
Res
ourc
e C
omm
ittm
ent
Long Term EfficiencyGain Following Implementation of Mitigations
Resources Required Short Term to Execute Mitigations
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Business AssessmentElements to ConsiderBusiness AssessmentElements to Consider
• Compliance History / Regulatory Commitments• License Status• Product Performance• Facility Condition / Performance (Manufacturing)• Business Infrastructure• Quality Systems• Capital / Resource Commitment• Leadership / Management Responsibility• Organization Structure• Talent• Internal Improvement Processes• Documentation Status
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Risk AssessmentRisk Assessment Matrix (example)Risk AssessmentRisk Assessment Matrix (example)
Overall Risk Post
Mitigation
Mitigation Verification
Mitigation or Decision
Overall Risk
Probability of
Occurrence
Severity of Impact
Impact On
Impact of Gap
Gap Identified
Product, Process,
System, etc.
Define Rating / Scoring Criteria to Help Prioritize Mitigation ActionsDefine Rating / Scoring Criteria to Help Prioritize Mitigation Actions
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Risk Control / MitigationsDecisions / Actions to be ConsideredRisk Control / MitigationsDecisions / Actions to be Considered
• System Redesign• Management Changes• Organization Changes• FCAs• Process Improvements• Facility Capital Improvements• Retirement of Product• Facility Closure /
Simplification
• Validation• Improved Documentation• Improved Operating
Mechanisms• Employee Education• CAPA• Labeling Enhancements • Product Improvements• Regulatory Submission
Updates
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Communication / TimingCommunication / Timing
Meet Fiscal RequirementsAs Necessary
(Material Decisions)Business Stakeholders
Ensure Patient SafetyAs Necessary Based on DecisionsCustomers / Patients
Update on Progress, Gain Feedback
Establish in Conjunction With AgencyRegulatory Agencies
AwarenessMonthlyBroad Organization
Process / Progress / Issue ReviewWeeklyQuality Organization
Process / Progress / Issue ReviewWeeklyRisk Management Team
Review / Discuss Overall Level of Risk, Key DecisionsMonthlySenior Management
ObjectiveFrequencyAudience
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
Communication / TimingCommunication / Timing
Time (days - example)Time (days - example)
Defin
e In
puts
to B
e
Inclu
ded
As a
Par
t of t
he
Busin
ess
Asse
ssm
ent
Con
duct
/ C
ompl
ete
Initi
al
Busi
ness
Ass
essm
ent
Dev
elop
Mea
sure
men
t
Syst
em
Com
plet
e R
isk
Anal
ysis
Prio
ritize
Miti
gatio
n
Actio
ns
Impl
emen
t Act
ions
Verif
y Ef
fect
iven
ess
Rea
sses
smen
t
Start 30 90 180 730(Dependant of Gaps and Mitigations Needed)
CommunicationCommunication
Development & Deployment of a Risk Based Compliance Turnaround Strategy
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
ExecutionKey ConsiderationsExecutionKey Considerations
• Well Developed Plan• Communication / Alignment of Organization• Objective / Fact Based Measurement• Employee Training & Development• Prioritization• Visible Management Commitment• Dedicated Resources• Third Party Review of Approach / Progress• Forecast of Activity• Commitment to Make the Difficult Decisions• Verification of Effectiveness
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
MeasurementMeasurement
Confirm Effectiveness of Mitigation ActionsAD Hoc ReviewThird Party Assessment
Results
Confirm Effectiveness of Mitigation ActionsManagement ReviewInternal Assessment Trends
Confirm Effectiveness of Mitigation ActionsManagement ReviewProduct / Process Trend Data
Ensure Timely Implementation of Mitigation ActionsScore CardMitigation Action Progress
Tracking
Verify Reduction of RiskRisk Analysis DocumentRisk Reduction Tracking
ObjectiveApproachMeasurement
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
MeasurementMitigation Action Score CardMeasurementMitigation Action Score Card
ForecastVerification of Effectiveness
Current Status
Mitigation 2Action 1
Action 2
Action 3
Mitigation 1Action 1
Action 2
Action 3
Initial StatusPerson ResponsibleMitigation
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Development & Deployment of a Risk Based Compliance Turnaround Strategy
•• Business AssessmentBusiness Assessment•• Risk AnalysisRisk Analysis•• Mitigation PlanMitigation Plan•• Effectiveness ReviewEffectiveness Review
•• Business DecisionsBusiness Decisions•• Measurement Feedback Measurement Feedback •• 33rdrd Party FeedbackParty Feedback•• Prioritization Prioritization •• Compliance EventsCompliance Events
•• Risk Management TeamRisk Management Team•• Dedicated ResourcesDedicated Resources•• CommunicationCommunication•• Execution and ReviewExecution and Review
•• Risk Reduction TrackingRisk Reduction Tracking•• Mitigation Score CardMitigation Score Card•• Management Review (Trend Data)Management Review (Trend Data)•• Assessment TrendsAssessment Trends•• Third Party Assessment ReviewThird Party Assessment Review
StrategyStrategy
DeploymentDeployment
MeasurementMeasurement
AdjustmentAdjustment
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Questions??Questions??